The 6-Month RR-TB Trial the FDA Should Be Studying as a Pragmatic Design Blueprint
A NEJM pragmatic trial of a 6-month rifampicin-resistant TB regimen just set a new benchmark for adaptive evidence generation...
GCP Breakdown at King’s College Hospital Just Clouded the Most Promising Parkinson’s Trial in Years
An MHRA inspection at King's College Hospital flagged department-wide GCP failures in the exenatide Phase 3 Parkinson's trial, triggering...
Clinical AI Is Being Deployed Faster Than It Can Be Trusted: Here’s the Network Trying to Fix That
43% of FDA-authorized AI clinical tools lack published validation data. A Columbia-led research network is building the governance framework...
Adaptive DBS Just Ran a Randomized Trial on Gait. The Endpoints FDA Needs to Validate Next Are Nowhere in Current Guidance.
A Nature Medicine feasibility trial on adaptive deep brain stimulation for Parkinson's gait signals a regulatory gap: FDA has...
Single-Cell Spatial Pharmacobiology Just Changed What “Drug Delivery” Means in Solid Tumor Trials
A Nature Biotechnology study using Single-cell Spatial Pharmacobiology exposes heterogeneous antibody delivery in solid tumors—what sponsors assumed about…
Aleniglipron’s Phase 2b Data Redraws the Oral GLP-1 Efficacy Map — And Raises Hard Questions for Phase 3 Design
Structure Therapeutics' aleniglipron hit 14.7% weight loss in Phase 2b, matching injectable benchmarks. Here's what the trial design signals...
Platform Trials Are Neurology’s Best Bet — So Why Is the FDA Still Treating Them Like Experiments?
The Lancet calls MAMS platform trials the fix for neurodegenerative drug failure. With 182 Alzheimer's trials active in 2025,...
Rogaratinib’s 41.7% Response Rate in SDH-Deficient GIST Rewrites the Playbook for Epigenetically Driven Trial Design
A 24-patient Phase 2 trial of rogaratinib hit 41.7% partial response in SDH-deficient GIST—a tumor that imatinib cures just...
Astegolimab’s Split Verdict: What ALIENTO’s Win and ARNASA’s Miss Reveal About COPD Trial Design
Astegolimab cut COPD exacerbations in Phase 2b but missed in Phase 3—a 14.5% gap that exposes critical flaws in...
CDR132L’s Phase 2 Miss: What a Well-Run Negative Trial Reveals About Heart Failure Drug Development
Cardior's CDR132L cleared safety hurdles in phase 2 but missed primary cardiac structure endpoints—a rigorous negative result that reshapes...